FDA Adverse Event
Injury
Summary report: N
JOERNS HALF LENGTH ASSIST DEVICE
MDR report key: 8586844
·
Received May 7, 2019
Report
- Report Number
- 3009402404-2019-00024
- Event Type
- Injury
- Date Received
- May 7, 2019
- Date of Event
- October 13, 2018
- Report Date
- May 7, 2019
- Manufacturer
- OPTIMA HEALTHCARE INC.
- Product Code
- FNL
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CT, US
- Reporter Occupation
- 501
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED TO THE MANUFACTURER BY THE END USER, PER THE END USER, THE PATIENT SUSTAINED A LACERATION TO THE LOWER RIGHT LEG WHILE BEING ASSISTED INTO BED DUE TO THE SIDE RAIL BEING INSTALLED ON THE WRONG SIDE OF THE BED. THE PATIENT WAS TRANSPORTED TO THE HOSPITAL AND RECEIVED SUTURES FOR THE LACERATION. COMPLAINT# (B)(4) WAS ENTERED INTO OUR SYSTEM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 381926 | JOERNS HALF LENGTH ASSIST DEVICE | HALF LENGTH RAIL | FNL | OPTIMA HEALTHCARE INC. | F17TMAL |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization |